Table 1.
Study overview (SPIRIT template)
| Study period | |||||||||
| Enrolment | Allocation | Postallocation | Close out | ||||||
| Timepoint | −2 weeks | 0 weeks | 2 weeks (±3 days) |
4 weeks (±3 days) |
6 weeks (±3 days) |
12 weeks (±1 week) |
18 weeks (±1 week) |
24 weeks (±1 week) |
+4–8 weeks |
| Enrolment: | |||||||||
| Eligibility screen | X | X | |||||||
| Informed consent | X | ||||||||
| Allocation | X | ||||||||
| Interventions: | |||||||||
|
|||||||||
| Methylphenidate
(X=uptitrate dose) (O=drug dispensed) |
O | O X |
O | O | O | O | |||
|
|||||||||
| Placebo
(X=uptitrate dose) (O=drug dispensed) |
O | O X |
O | O | O | O | |||
| Assessments | |||||||||
| Safety bloods (FBC/LFT/U+Es) | X | X | X | X | X | ||||
| Safety questionnaire | X | X | X | X | X | X | |||
| Pregnancy test | X | X | |||||||
| ECG | X | X | X | X | X | X | |||
| Spirometry | X | X | X | ||||||
| MSWT | X | X | X | ||||||
| Accelerometer (7 days) | X | X | X | ||||||
| Questionnaires | |||||||||
| FAS | X | X | X | X | X | X | X | X | X |
| FACIT-F | X | X | X | X | X | X | X | X | |
| HADS | X | X | X | X | X | X | |||
| SF-36 | X | X | X | X | X | X | |||
| EQ5D | X | X | X | X | X | X | |||
| KSQ | X | X | X | X | X | X | |||
| Costs | X | X | X | ||||||
| PSQI | X | X | X | X | |||||
| Exit questionnaire | X | ||||||||
| Focus group (post-trial) | X | ||||||||
In addition, all participants receive telephone calls at weeks 1, 3, 5, 8, 10, 14, 16, 10 and 22 to review safety (emergence of side effects).
EQ5D, EuroQoL-5D-5L; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; FAS, Fatigue Assessment Scale; FBC, full blood count; HADS, Hospital Anxiety and Depression Score; KSQ, King’s Sarcoidosis Questionnaire; LFT, liver function test; MSWT; modified shuttle walk test; PSQI, Pittsburgh Sleep Quality Index; SF-36, Short Form-36; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; U+Es; urea + electrolytes.